Products

Date: 2018-10-18

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Flucelvax® Tetra

Compound: influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated and prepared in cell cultures, of 4 different influenza virus strains (two A subtypes and two B types)

Therapeutic area: Infectious diseases

Action mechanism: vaccine

Company: Seqirus Netherlands, subsidiary of CSL (Australia)

Disease: prophylaxis of influenza in adults and children from 9 years of age

Latest news:

• • On October 18,  2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Flucelvax® Tetra, intended for prophylaxis against influenza. Flucelvax ®Tetra will be available as a suspension for injection in pre-filled syringes. It provides active immunisation against influenza virus by inducing humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses. The benefits with Flucelvax Tetra are its ability to induce an immune response in vaccinees similar to the previously authorised trivalent cell-based vaccine, with the added benefit of potentially protecting against both circulating type B viruses. The most common side effects are pain at the injection site, headache, fatigue, myalgia, erythema and induration.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE: 2018-10-18

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes